Mesh spacer hybrid

ABSTRACT

A modular implant for performing an intervertebral fusion on adjacent vertebral bodies in a patient including a first spacer portion, a second spacer and a container having a first end and a second end, the first end of the container constructed to operably engage a first spacer and the second end of the container constructed to operably engage the second spacer.

PRIORITY

This application is a continuation of U.S. patent application Ser. No.15/078,959, filed Mar. 23, 2016, which is a continuation of U.S. patentapplication Ser. No. 13/951,162, filed Jul. 25, 2013, which claims thepriority benefit of U.S. Provisional Application Ser. No. 61/675,668,filed on Jul. 25, 2012 and the priority benefit of U.S. ProvisionalApplication Ser. No. 61/793,923, filed on Mar. 15, 2013, and all offoregoing are hereby incorporated herein by reference in their entirety.

FIELD

The present invention generally relates to a PEEK spacer/Mesh containerhybrid for use in the spine. More particularly, the present inventionrelates to a PEEK spacer/Mesh container hybrid configured to be placedin the spine via a percutaneous or minimally invasive access opening.

BACKGROUND

PEEK spacers are commonly used in spine surgery, particularly fusionsurgery. Often bone graft or other fill material is used with a spacerto help promote bony fusion. It is desirable that the fill materialcontacts the vertebral endplates while the spacer provides structuralsupport. In an attempt to minimize the size of spacers, traditional PEEKspacers lack adequate cavities for fill material insertion. As such,fill material is often packed around the spacer, rather than in thespacer. Uncontained fill material does pose a risk of migrating tosurrounding anatomy which can lead to patient injury.

It is desirable to have a spacer small enough to be inserted via aminimally invasive or even percutaneous approach, while allowing forgreater fill material containment and fill material contact with thevertebral endplates. There is a need for a PEEK spacer that is smallenough to fit through an MIS or percutaneous approach, yet able toexpand upon insertion to fully support and/or stabilize theintervertebral space while containing fill material therewithin.

SUMMARY

The present invention, according to certain embodiments, comprises amodular implant for performing an intervertebral fusion on adjacentvertebral bodies in a patient. The implant includes a first spacerportion, a second spacer and a container having a first end and a secondend, the first end of the container constructed to operably engage afirst spacer and the second end of the container constructed to operablyengage the second spacer.

The detailed technology and preferred embodiments implemented for thesubject invention are described in the following paragraphs accompanyingthe appended drawings for people skilled in this field to wellappreciate the features of the claimed invention. It is understood thatthe features mentioned hereinbefore and those to be commented onhereinafter may be used not only in the specified combinations, but alsoin other combinations or in isolation, without departing from the scopeof the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts a perspective view of an embodiment of the presentinvention.

FIG. 2 depicts a perspective view of an embodiment of the presentinvention.

FIG. 3 depicts a perspective view of an embodiment of the presentinvention

FIG. 4 depicts a perspective view of an embodiment of the presentinvention

FIG. 5 depicts a perspective view of an embodiment of the presentinvention.

FIG. 6 depicts a perspective view of an embodiment of the presentinvention.

FIG. 7 depicts a perspective view of an embodiment of the presentinvention.

FIG. 8 depicts a perspective view of an embodiment of the presentinvention.

FIG. 9 depicts a perspective view of an embodiment of the presentinvention.

FIG. 10 depicts a perspective view of an embodiment of the presentinvention.

FIG. 11 depicts a perspective view of an embodiment of the presentinvention.

FIG. 11a depicts a top perspective view of the embodiment of the presentinvention depicted in FIG. 11.

FIG. 12 depicts a perspective view of an embodiment of the presentinvention.

FIG. 13 depicts a perspective view of an embodiment of the presentinvention.

FIG. 14 depicts a perspective view of an embodiment of the presentinvention.

FIG. 15 depicts a perspective view of an embodiment of the presentinvention.

FIG. 16 depicts a perspective view of an embodiment of the presentinvention.

FIG. 17 depicts a perspective view of an embodiment of the presentinvention.

FIG. 18 depicts a perspective view of an embodiment of the presentinvention.

FIG. 19 depicts a perspective view of an embodiment of the presentinvention.

While the invention is amenable to various modifications and alternativeforms, specifics thereof have been shown by way of example in thedrawings and will be described in detail. It should be understood,however, that the intention is not to limit the invention to theparticular example embodiments described. On the contrary, the inventionis to cover all modifications, equivalents, and alternatives fallingwithin the spirit and scope of the invention as defined by the appendedclaims. For illustrative purposes, cross-hatching, dashing or shading inthe figures is provided to demonstrate sealed portions and/or integratedregions or devices for the package.

DETAILED DESCRIPTION

In the following descriptions, the present invention will be explainedwith reference to example embodiments thereof. However, theseembodiments are not intended to limit the present invention to anyspecific example, embodiment, environment, applications or particularimplementations described in these embodiments. Therefore, descriptionof these embodiments is only for purpose of illustration rather than tolimit the present invention. It should be appreciated that, in thefollowing embodiments and the attached drawings, elements unrelated tothe present invention are omitted from depiction; and dimensionalrelationships among individual elements in the attached drawings areillustrated only for ease of understanding, but not to limit the actualscale.

As shown in FIGS. 1-17, an embodiment of the present invention mayinclude a spacer body and a container attached or otherwise operablyconnected to the spacer body. The spacer may be comprised of PEEK or anyother biocompatible material or combination thereof. Spacer body mayprovide structural support between the adjacent vertebrae. The containermay be comprised of PET or any other biocompatible material orcombination thereof. The container may be comprised of material suchthat the container is flexible and/or conformable to the patient'sanatomy.

The container may contain bone graft, bone substitute or any otherbiocompatible fill material. Such fill material may promote bony fusion.The container may be porous to allow the fill material to contact thevertebral endplates, promoting bony fusion. According to an embodimentof the present invention, the spacer hybrid of the present invention maybe inserted into an intervertebral disc space in a first unexpandedconfiguration and then the container portion of the device may be filledwith fill material expanding the device to a second expandedconfiguration. According to another embodiment, mechanical tools may beused to open the device of the present invention from a first unexpandedconfiguration to a second expanded configuration. Expansion of thehybrid device may distract the adjacent vertebrae.

FIG. 1 depicts an embodiment of the hybrid device 1 of the presentinvention which may include a PEEK spacer portion 10 and a containerportion 16. PEEK portion 10 may include a body 14 and arms 12 a and 12 bmovably connected to body 14. Container 16 may be configured to receiveand contain biocompatible fill material. Hybrid device 1 of thisembodiment may be inserted between two vertebrae in a collapsed stateand expanded upon the introduction of fill material into container 16and/or by mechanical tools.

FIG. 2 depicts another embodiment of a hybrid fusion device 2 accordingto the present invention. The embodiment depicted in FIG. 2 may includea spacer portion 20 comprised of PEEK or other biocompatible material.Spacer portion 20 may include at least one opening 24. Hybrid device 2may also include a container 22 disposed therewithin. Container 22 maybe configured to receive and contain biocompatible fill material.

FIG. 3 depicts yet another embodiment of the hybrid device 3 of thepresent invention. Hybrid device 3 may include spacer body portions 30 aand 30 b. According to this embodiment, container 32 may be disposedbetween spacer body portions 30 a and 30 b. At least one of spacer bodyportions 30 a and 30 b may include a fill opening or port to facilitatefilling container 32 with fill material. Hybrid device 3 may be insertedinto an intervertebral space in an unexpanded position and expanded insitu by the insertion of fill material into container 32 and/or bymechanical tools.

FIG. 4 depicts a hybrid device 4 according to the present invention.Hybrid device 4 may include a curved spacer body 40 configured to fitadjacent container 42 in an intervertebral space.

FIG. 5 depicts yet another hybrid device 5 according to the presentinvention. Hybrid device 5 includes spacer body portions 50 a-d. Spacerbody portions 50 a-d may be movably connected to each other. Suchmovable connection may be a pivot or other desired connection. Hybriddevice 5 may include any desired number of body portions as such, thefour body portions depicted in FIG. 5 is merely illustrative. Container52 may be disposed within spacer body portions such that container 52may receive and contain fill material. Hybrid device 5 may be insertedinto an intervertebral space in an unexpanded position and expanded insitu by the insertion of fill material into container 52 and/or bymechanical tools.

FIG. 6 depicts another embodiment of a hybrid device 6 of the presentinvention. Hybrid device 6 may include spacer portions 60 a and 60 b.Container 62 may be disposed between spacer portions 60 a and 60 b.Spacer portions 60 a and 60 b may be configured to contact adjacentvertebral endplates. Hybrid device 6 may be inserted into anintervertebral space in an unexpanded position and expanded in situ bythe insertion of fill material into container 62 and/or by mechanicaltools.

FIG. 7 depicts an alternate embodiment of hybrid device 7 according tothe present invention. Hybrid device 7 may include spacer portions 70 aand 70 b and container portion 72. Once hybrid device 7 is placed in anintervertebral space, container portion 72 may be configured tofacilitate the distraction of adjacent vertebrae. Container portion 72may be filled with fill material in situ. Upon filling, container 72 mayexert pressure on spacer portions 70 a and 70 b thereby distractingand/or moving adjacent vertebral endplates. Hybrid device 7 may beinserted into an intervertebral space in an unexpanded position andexpanded in situ by the insertion of fill material into container 72and/or by mechanical tools.

FIG. 8 depicts yet another hybrid device 8 according to the presentinvention. Device 8 may include spacer 80 and container portion 82.Container portion 82 may be connected to spacer portion 80 such thatupon filling, container portion 82 expands outwardly from spacer portion80. Hybrid device 8 may be inserted into an intervertebral space in anunexpanded position and expanded in situ by the insertion of fillmaterial into container 82 and/or by mechanical tools.

FIG. 9 is another view of an embodiment of a hybrid device 9 accordingto the present invention. Device 9 includes a spacer portion 90 havingmovable arms 92 a and 92 b and body portion 94. Container 96 may beconnected to spacer 90 such that container 96 may receive fill materialupon insertion into the intervertebral space. Hybrid device 9 may beinserted into an intervertebral space in an unexpanded position andexpanded in situ by the insertion of fill material into container 92and/or by mechanical tools.

FIG. 10 depicts an alternate view of hybrid device 10 according to thepresent invention. Hybrid device 10 may include spacer portions 100 aand 100 b and container portion 102. Once hybrid device 10 is placed inan intervertebral space, container portion 102 may be configured tofacilitate the distraction of adjacent vertebrae. Container portion 102may be filled with fill material in situ. Upon filling, container 102may exert pressure on spacer portions 100 a and 100 b therebydistracting and/or moving adjacent vertebral endplates. Hybrid device 10may be inserted into an intervertebral space in an unexpanded positionand expanded in situ by the insertion of fill material into container102 and/or by mechanical tools.

FIG. 11 depicts yet another embodiment of the present invention. Device11 may include spacer portion 110 and container portion 112. Hybriddevice 11 may be inserted into an intervertebral space in an unexpandedposition and expanded in situ by the insertion of fill material intocontainer 112 and/or by mechanical tools.

FIG. 12 depicts a hybrid device 12 according to the present invention.Hybrid device 12 may include a curved spacer body 120 configured to fitadjacent container 122 in an intervertebral space. FIG. 12 depicts anunexpanded container 122 and an expanded container 122 b. Hybrid device12 may be inserted into an intervertebral space in an unexpandedposition and expanded in situ by the insertion of fill material intocontainer 122 and/or by mechanical tools.

FIG. 13 depicts an expanded view of an embodiment of the presentinvention. Hybrid device 13 may include spacer portions 130 a and 130 b.According to this embodiment, container 132 may be disposed betweenspacer body portions 130 a and 130 b. At least one of spacer bodyportions 130 a and 130 b may include a fill opening or port tofacilitate filling container 132 with fill material. Hybrid device 13may be inserted into an intervertebral space in an unexpanded positionand expanded in situ by the insertion of fill material into container132 and/or by mechanical tools.

FIG. 14-16 depict an embodiment of the present invention, hybrid devices14-16 respectively, wherein a first spacer body 140 is configured toreceive a first end of container 144 and a second spacer body 142 a and142 b is configured to receive a second end of container 144. The firstand second spacer bodies may be comprised of one or more parts. Aninsertion rod 146 may insert the container into the first and secondspacer bodies. Rod 146 may include an anti-rotation locking ring 148that engages with the distal tip of inner 150. Once the locking ring 148is engaged, the implant will not rotate. Ring 148 may be disengaged toallow implant rotation.

Spacer bodies 140 and 142 may include markings 152 a-d which may allowvisualization of the implant upon imaging. Markings 152 a-d may projectoutward to engage the surrounding anatomy. Spacer bodies 140 and 142 mayinclude other desired outward projections to engage the surroundinganatomy.

Spacer bodies 140 and 142 may include grooves on their inner diametersand utilize locking rings to receive and retain container 144. Otherretention mechanisms may be used.

In use, the implant may be inserted into a prepared intervertebralcavity. The implant may be inserted with an empty container such thatthe implant may be placed through a MIS or percutaneous approach. Onceplaced, container 144 may be filled with bone graft or any combinationof desired fill materials. In an embodiment, at least one of spacerbodies 140 and 142 may include a fill opening or a fill port, such thatfill material may be placed into container 144. In another embodiment,fill material may be placed directly into container 144. As container144 is filled, first spacer body 140 and second spacer body 142 may moveapart creating an appropriate implant footprint for the particularpatient's anatomy. First spacer body 140 and second spacer body 142 mayprovide structural support on the strongest part of the adjacentvertebrae. While container 144 may provide graft and fill materialcontainment and further may provide a scaffold for bone growth andfusion because container 144 is placed in the most vascular part of theadjacent vertebra.

Hybrid devices 14-16 may be inserted into an intervertebral space in anunexpanded position and expanded in situ by the insertion of fillmaterial into container 144 and/or by mechanical tools.

FIG. 17 depicts a hybrid device 17 according to another embodiment ofthe present invention. Hybrid device 17 may include spacer body portions170 and 172. Container 174 may be disposed between spacer body portions170 and 172. First spacer body 170 is configured to receive a first endof container 174 and a second spacer body 172 is configured to receive asecond end of container 174. The first and second spacer bodies may becomprised of one or more parts. Hybrid device 17 may further include atleast one connecting rod 176. Connecting rod 176 may connect spacer 170to spacer 172. Connecting rod 176 may lock container 174 into positionwithin spacer bodies 170 and 172. Connecting rod 176 may include a fillopening 178.

Spacer bodies 170 and 172 may include markings which may allowvisualization of the implant upon imaging. Markings may project outwardto engage the surrounding anatomy. Spacer bodies 170 and 172 may includeother desired outward projections 182 to engage the surrounding anatomy.

Spacer bodies 170 and 172 may include grooves on their inner diametersand utilize locking rings to receive and retain container 174. Otherretention mechanisms may be used.

In use, the implant may be inserted into a prepared intervertebralcavity. The implant may be inserted with an empty container such thatthe implant may be placed through a MIS or percutaneous approach. Onceplaced, container 174 may be filled with bone graft or any combinationof desired fill materials. In an embodiment, at least one of spacerbodies 170 and 172 may include a fill opening or a fill port 180, suchthat fill material may be placed into container 174. In anotherembodiment, fill material may be placed directly into container 174. Ascontainer 174 is filled, first spacer body 170 and second spacer body172 may move apart creating an appropriate implant footprint for theparticular patient's anatomy. First spacer body 170 and second spacerbody 172 may provide structural support on the strongest part of theadjacent vertebrae. While container 174 may provide graft and fillmaterial containment and further may provide a scaffold for bone growthand fusion because container 174 is placed in the most vascular part ofthe adjacent vertebra.

In an alternate embodiment of hybrid device 17, depicted in FIGS. 18 and19, the device may include an angulation feature 182 that provides forangulation between first spacer body 170 and second spacer body 172.Angulation feature 182 allows device 18 to accommodate variations in apatient's anatomy and/or to accommodate the curvature at the L5-S1junction. Angulation feature 182 may be a mechanical connection such asdepicted in FIG. 18 or a flexible material such as nitinol, as depictedin FIG. 19 or any other suitable angulation feature.

Hybrid device 17 may be inserted into an intervertebral space in anunexpanded position and expanded in situ by the insertion of fillmaterial into container 174 and/or by mechanical tools.

The entire disclosure of U.S. patent application Ser. No. 13/557,993,filed Jul. 25, 2012, entitled FAR LATERAL SPACER, is hereby incorporatedby reference herein.

The present invention may be embodied in other specific forms withoutdeparting from the spirit or essential attributes thereof, and it is,therefore, desired that the present embodiment be considered in allrespects as illustrative and not restrictive. Those skilled in the artmay recognize other equivalents to the specific embodiment describedherein which equivalents are intended to be encompassed by the claimsattached hereto.

What is claimed is:
 1. An implant for performing an intervertebralfusion on adjacent vertebral bodies in a patient, and for being locatedentirely in a space between opposing end plates of the adjacentvertebral bodies, the implant comprising: a non-threaded firstintervertebral spacer body, defining a top side oriented to contact afirst one of the opposing end plates when the implant is implanted inthe space between opposing end plates and an opposing bottom sideoriented to contact a second one of the opposing end plates when theimplant is implanted in the space between opposing end plates; anon-threaded second intervertebral spacer body; and a porous andexpandable enclosed container, the container having a first end and alongitudinally opposing second end, wherein the first end of thecontainer is coupled to the first intervertebral spacer body and thesecond end of the container is coupled to the second intervertebralspacer body, and wherein the container is exposed between the firstintervertebral spacer body and the second intervertebral spacer body tothe opposing end plates when the implant is implanted in the spacebetween opposing end plates.
 2. The implant of claim 1, wherein thefirst and second intervertebral spacers each have a vertical heightdimension defined between the opposing top and bottom sides such thateach of the first and second intervertebral spacers can be implanted ina direction parallel to the opposing end plates.
 3. The implant of claim1, wherein at least one of the first intervertebral spacer body and thesecond intervertebral spacer body includes at least one fill openingthat extends longitudinally through at least one of the firstintervertebral spacer body and the second intervertebral spacer body. 4.The implant of claim 1, wherein at least one of the first and secondintervertebral spacer bodies includes markings disposed on one of thetop or bottom surfaces.
 5. The implant of claim 4, wherein the markingsproject vertically outward to engage the surrounding anatomy.
 6. Theimplant of claim 1, wherein at least one of the spacer bodies includesvertically facing outward projections to engage the surrounding anatomy.7. The implant of claim 1, further including a connecting rod extendinglongitudinally between the first intervertebral spacer body and thesecond intervertebral spacer body, and passing through the container. 8.The implant of claim 7, wherein the connecting rod includes at least onefill opening in communication with an interior of the container.
 9. Theimplant of claim 1, including an angulation feature.
 10. The implant ofclaim 1 wherein the container is comprised of a conformable material.11. The implant of claim 1, wherein the top side of the firstintervertebral spacer body defines a textured surface that is orientedto engage one of the opposing end plates when implanted into the spacebetween opposing end plates.
 12. The implant of claim 1, wherein each ofthe first and second intervertebral spacer bodies define a non-circularouter perimeter in a cross-section taken perpendicular to theirlongitudinal axis.
 13. An implant for performing an intervertebralfusion on adjacent vertebral bodies in a patient, wherein each of theadjacent vertebral bodies defines an end plate and wherein each of theend plates faces one another to define an intervertebral spacetherebetween, the implant comprising: a first intervertebral spacer bodyhaving a longitudinal length dimension defined parallel to the endplates and a vertical height dimension perpendicular to the horizontalwidth dimension and normal to the end plates; a second intervertebralspacer body having a longitudinal length dimension defined parallel tothe end plates and a vertical height dimension perpendicular to thehorizontal width dimension and normal to the end plates; and a porousand expandable enclosed container, having a longitudinal lengthdimension defined parallel to the end plates, wherein the longitudinallength dimension of the container is greater than the longitudinallength dimension of the first intervertebral spacer body and greaterthan the longitudinal length dimension of the second intervertebralspacer body, wherein the first intervertebral spacer body is coupled tothe first end of the container, and wherein the second intervertebralspacer body is coupled to the second end of the container.
 14. Theimplant of claim 13, further including a connecting rod extendinghorizontally between the first spacer body and the second spacer body,and passing through the enclosed container.
 15. The implant of claim 14,wherein the connecting rod includes at least one fill opening incommunication with an interior of the enclosed container.
 16. Theimplant of claim 15, wherein at least one of the first intervertebralspacer body and the second intervertebral spacer body includes at leastone fill opening that extends horizontally through at least one of thefirst intervertebral spacer body and the second intervertebral spacerbody and that communicates with at least one fill opening of theconnecting rod.
 17. The implant of claim 14, wherein the connecting rodis rotationally rigid and secured to each of the first and secondintervertebral spacer bodies such that the first intervertebral spacerbody cannot rotate with respect to the second intervertebral spacer bodyabout a longitudinal axis of the rod.
 18. The implant of claim 14,wherein the connecting rod includes at least one fill opening incommunication with an interior of the enclosed container.
 19. Theimplant of claim 13, wherein the first spacer body includes a fillopening that extends longitudinally through the first intervertebralspacer body.
 20. The implant of claim 19, wherein the secondintervertebral spacer body includes a textured end plate contactingsurface.
 21. An implant for performing an intervertebral fusion onadjacent vertebral bodies in a patient, and for being located entirelyin a space between opposing end plates of the adjacent vertebral bodies,the implant comprising: a porous and expandable container including afirst end, a second end and an enclosed interior space; a first rigidand non-threaded intervertebral spacer body coupled to a first end ofthe container; a second rigid and non-threaded intervertebral spacerbody coupled to a second end of the container; and a rod spanningbetween the first spacer body and the second spacer body, and extendingthrough the container, wherein the rod is disposed completely within theenclosed interior space of the container for an entire expanse betweenthe first spacer body and the second spacer body, wherein a fill openingis defined through the first spacer body which communicates with therod, and wherein the rod includes a fill channel that communicates withthe fill opening and with the interior space of the container.
 22. Theimplant of claim 21, wherein at least one of the first and secondintervertebral spacer bodies defines a textured end plate contactingsurface that is oriented to face at least one of the opposing end plateswhen implanted between the opposing end plates.